Tiffany Dorotheo, Associate Director, Regulatory Operations, has in-depth experience preparing regulatory submissions to the Food and Drug Administration and other Health Authorities. She supports early to late-stage development and complex submissions made to INDs, NDAs, BLAs, CTAs, NDSs, MAAs, and Master Files. She also has experience maintaining and upgrading systems and procedures, authoring and collaborating on work instructions and workflows for the Regulatory Operations group to ensure that the company’s practices are in conformance with the latest health authority and industry submissions standards.